FDAFDA · Food and drugs·Recall number Z-1692-2017
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Published April 5, 2017 · Recall initiated: February 10, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- United Orthopedic Corporation
- Distributor
- Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
- Lot
- Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Taiwan
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